Ondine Biomedical's Steriwave Receives Regulatory Approval in the UAE
核心洞察
Ondine Biomedical (搜索) has secured regulatory approval in the United Arab Emirates (UAE) for its Steriwave nasal decolonization system, designed to reduce healthcare-associated infections (搜索) (HAIs).
Steriwave employs a light-activated antimicrobial technology to eliminate pathogens in the nasal passages, offering a rapid, five-minute treatment that minimizes the risk of antimicrobial resistance.
The UAE represents a growing market in the Middle East for medical tourism, with wellness tourists spending an estimated $5.4 billion, marking a significant increase from $2.1 billion in 2020.
Ondine Biomedical (搜索) Inc. has announced that its Steriwave nasal decolonization system has received regulatory approval in the United Arab Emirates (UAE). This approval allows Ondine to market Steriwave for reducing healthcare-associated infections (搜索) (HAIs) in patients undergoing surgery within the UAE.
The UAE, with a population of 9.4 million, is an expanding market in the Middle East, increasingly recognized as a center for medical excellence. The region attracts medical tourists from across the Middle East and Asia, with wellness tourism expenditures estimated at $5.4 billion, up from $2.1 billion in 2020.
Carolyn Cross, CEO of Ondine Biomedical (搜索), stated, "We are looking forward to bringing the infection-reducing benefits of Steriwave nasal decolonization to the United Arab Emirates and other Middle Eastern Markets. We believe that adding Steriwave to current presurgical and ICU protocols can help these countries to address the growing threat from antimicrobial resistant infections in hospitals."
Addressing Healthcare-Associated Infections
HAIs remain a significant global challenge, leading to substantial costs, preventable deaths, and human suffering. In the United States, HAIs are the fifth most common cause of mortality in acute-care hospitals. Post-surgical infections can prolong recovery times and necessitate extended antibiotic treatment, a practice that healthcare systems are actively trying to reduce. The average hospital cost per surgical site infection (SSI) in the U.S. is approximately $20,000.
Nasal decolonization is recommended in the 2016 World Health Organization (WHO) global guidelines for preventing surgical site infections (搜索) and by the Society for Healthcare Epidemiology of America (SHEA) guidelines, which recommend nasal decolonization for major surgical procedures.
Steriwave Technology
Steriwave utilizes a patented light-activated agent to rapidly eliminate infection-causing pathogens within five minutes. This rapid action minimizes the opportunity for pathogens to develop resistance, making it an effective alternative to antibiotics. Hospitals using Steriwave have reported high levels of staff and patient compliance. A 2023 study demonstrated that Steriwave is highly effective (>99.99% kill rate in 20 seconds) against both moderately drug-resistant (MDR) and extensively drug-resistant (XDR) pathogens.
Steriwave's nasal photodisinfection system employs a proprietary light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses, and fungi colonizing the nose. Administered by trained healthcare professionals, the treatment involves applying the photosensitizer to each nostril using a nasal swab, followed by illumination with a specific wavelength of red laser light for less than five minutes. This process activates the photosensitizer, causing an oxidative burst lethal to all types of pathogens without long-term adverse effects on the nasal microbiome. Unlike antibiotics, which have reported resistance rates as high as 81%, pathogens do not develop resistance to Steriwave therapy.